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Early Detection of Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539162
First received: October 3, 2007
Last updated: November 19, 2014
Last verified: November 2014

October 3, 2007
November 19, 2014
July 2001
July 2016   (final data collection date for primary outcome measure)
Rate of increase in CA 125 levels over time [ Time Frame: Once a year (Initial CA 125 test followed by another in 3 months or 12 months depending on initial assessment) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00539162 on ClinicalTrials.gov Archive Site
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Early Detection of Ovarian Cancer
Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.

Currently, there are no effective tests to detect ovarian cancer at its earliest stage. CA-125 is an FDA approved marker for detecting recurrence of disease in women who have already had ovarian cancer.

Women who are at least 50 years old, who are post-menopausal, are eligible for this study. Patients will have their blood drawn each year for the duration of the study. The amount of blood drawn will be about 2 to 3 tablespoons.

Women will need to provide the name of a gynecologist or qualified healthcare professional willing to provide follow up care if it is indicated.

Each time blood is drawn, the CA-125 analysis will be performed. If the CA-125 analysis shows that patients are at low risk of developing ovarian cancer, they will be asked to repeat the blood test in one year. If the CA-125 analysis shows that patients are at a slightly higher risk, they will be asked to repeat the blood test in 3 months. If the CA-125 analysis shows that patients are at an even higher risk, they will be asked to have a transvaginal ultrasound.

An ultrasound test uses sound waves to evaluate the position, size, and shape of the ovaries. During an ultrasound, a small probe will be used to generate and measure sound waves. It will be placed in the vagina. Based on the results of the transvaginal ultrasound, patients and their physician will discuss options for management. At this point, standard clinical management ensues.

Patient's will be asked to complete a questionnaire. Patient's will be contacted to obtain follow up information, and to ensure that they return for their blood draws. When patients return for screening, their health status will be updated prior to, or at each visit. Any changes to the participant's medical or cancer history will be obtained at that time. Attempts will be made to contact patients by telephone or letter that are not seen during visits. Updates to each participant's cancer history may also be obtained via M. D. Anderson's medical informatics section, if an M. D. Anderson patient, or state tumor registries.

Patients' names will not be used at any time. Each sample will have an identifying number. Only the study coordinator will have the match between the identifying number and the patient's name.

This is an investigational study. A total of 30,000 women will take part in this study. Women will be enrolled in the study during Year 1 thru Year 15 of the study. An additional year, Year 16, will be for follow-up. For example, a woman enrolled in the beginning of Year 1 will participate for sixteen years. A woman enrolled in the beginning of Year 2 will participate for fifteen years and a woman enrolled in the beginning of Year 3 will participate for fourteen years and so on. Women will be enrolled at John Stoddard Cancer Center, Des Moines, Iowa, Women's and Infant's Hospital in Providence, Rhode Island; The University of Texas M.D. Anderson Cancer Center, Houston, Texas, UT Southwestern, Dallas, Texas and Carol G. Simon Cancer Center, Morristown, New Jersey. In order to increase community participation in Houston, Texas a free-standing physician practice, Obstetrics and Gynecology Associates (OGA), has been been added.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Yearly blood draw of 2 to 3 tablespoons, with CA-125 analysis performed each time. Urine specimen obtained at each UT MDACC visit.

Non-Probability Sample

Study participants considered to be at low risk for ovarian cancer.

Ovarian Cancer
Behavioral: Questionnaire
Completed during follow up visits.
Other Name: Survey
CA 125 Analysis
Participants considered to be at low risk for ovarian cancer.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9500
Not Provided
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Female, >/= 50 years old or less than 75 years old
  2. Postmenopausal (>/= 12 months amenorrhea)
  3. Have at least one ovary
  4. Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
  5. Willingness to return to UTMD Anderson Cancer Center (UTMDACC)for CA 125 blood tests annually or earlier if indicated
  6. 6) Willingness to return to UTMDACC to undergo transvaginal ultrasound if indicated.
  7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:

  1. Female: Less than 50 years old or older than 75 years
  2. Psychiatric or psychological or other conditions which prevent a fully informed consent.
  3. Prior removal of both ovaries.
  4. Active non-ovarian malignancy.
  5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERM (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
  6. High risk for ovarian cancer : a. known mutation in BRCA1 of BRCA2.
  7. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal and one post menopausal breast cancer. These conditions can also be met using the participant and one 1st or 2nd degree female relative.
  8. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer.
  9. 1st or 2nd degree male relative with breast cancer diagnosed at any age. First degree relative defined as: children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.
  10. HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
Female
50 Years to 74 Years
No
Contact: Karen H. Lu, MD 713-563-4579
United States
 
NCT00539162
ID01-022
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP